MannKind FY Conference Summary Company Overview - MannKind Corporation (NasdaqGM:MNKD) has been in operation for 34 years, primarily known for inhalation therapeutics and diabetes treatments [4][5] - The company is diversifying away from diabetes, focusing on applying inhalation technology in various therapeutic areas [4] Recent Developments - MannKind has entered late-stage development programs, including cofazamine in Phase 3 and nintedanib in Phase 2 [4] - The company has partnered with United Therapeutics, which has positively impacted the performance of Tyvaso DPI [4][5] - A significant acquisition of SC Pharmaceuticals was announced, marking a transformative decision for the company [5][14] Key Growth Drivers - Upcoming label change for Afrezza in October 2025, aimed at resolving dosing issues [9] - Anticipated acceptance of the pediatric file for Afrezza within the next few weeks [9] - Enrollment of the 100th evaluable patient for cofazamine expected in the next 60 to 90 days [9] - SC Pharmaceuticals acquisition expected to close in Q4 2025 [9][10] - Multiple catalysts anticipated over the next 18 months, including pediatric approval and autoinjector developments [11] SC Pharmaceuticals Acquisition - The acquisition was driven by the need for a complementary asset and the potential for faster growth [14] - The overlap between diabetes and heart failure markets was highlighted, with a significant percentage of heart failure patients also having diabetes [15] - The integration plan focuses on maximizing the sales force's effectiveness across both companies [15][20] Tyvaso DPI and IPF Developments - Positive results from the TEPTEN-2 study are expected to enhance the royalty stream from United Therapeutics [21] - United Therapeutics is heavily investing in idiopathic pulmonary fibrosis (IPF), with a billion-dollar commitment to manufacturing and development [22] - MannKind is confident in the FDA's expedited review process for Tyvaso DPI and its potential impact on patients [22][23] Nintedanib Phase 2 Trial - The trial is expected to start soon, with top-line data anticipated in the first half of 2027 [30] - The study will involve 228 patients, testing different dosing regimens [30][34] - Confidence in the inhaled approach is based on previous studies showing no significant gastrointestinal side effects [41] Afrezza Relaunch Strategy - The label change for Afrezza is seen as a critical step for its relaunch, particularly in pediatric populations [62][64] - A new marketing campaign and sales materials are set to be implemented in Q4 2025 [62] - The company aims to target a broader market, including pediatric patients and those with gestational diabetes [72][75] Financial Outlook - MannKind is positioned for a challenging financial year ahead but has sufficient capital to support its initiatives [78] - The company anticipates significant revenue growth from multiple product launches and clinical trial results in 2026 [78] - The management emphasizes the importance of successful integration of SC Pharmaceuticals to build confidence for future M&A opportunities [81] Conclusion - MannKind is at a pivotal moment with multiple upcoming catalysts and a strong focus on expanding its product offerings and market presence [84] - The company believes it remains undervalued compared to peers, with a solid revenue growth outlook and cash reserves to fund innovation [84]

Financial Performance & Pipeline Funding - MannKind reported total revenue of $78 million for Q1 2025, an 18% increase compared to $66 million in Q1 2024[86] - Tyvaso DPI collaboration generated $30 million in royalty revenue in Q1 2025, a 32% increase compared to Q1 2024[11, 86] - Manufacturing-related revenue from Tyvaso DPI was $29 million in Q1 2025, a 16% year-over-year increase[11, 50] - The company's cash, cash equivalents, and investments stand at $198 million[13] - Tyvaso DPI revenue for the last four quarters reached $1.1 billion[50] Afrezza Development & Market Expansion - Afrezza demonstrated a 20% growth in new prescriptions (NRx) in Q1 2025 compared to Q1 2024[11] - The company anticipates a label update for Afrezza in Q4 2025[11] - MannKind expects to submit a supplemental Biologics License Application (sBLA) for pediatric indication expansion in mid-2025[11] - Projected sales of Afrezza are estimated to be over $200 million, with every 10% of pediatric market share potentially adding ~$150 million in annual revenue[41] MNKD-101 & MNKD-201 Clinical Trials - MannKind expects to meet the interim enrollment target for the Clofazimine Inhalation Suspension (MNKD-101) Phase 3 global enrollment by the end of 2025, with approximately 70 patients randomized to date[11] - The company plans to advance Nintedanib DPI (MNKD-201) into the next phase of global development in the second half of 2025[11]